QA Specialist, Drug Product — Validation & GMP Oversight
FUJIFILM Holdings America Corporation
FUJIFILM Holdings America Corporation is seeking a QA Specialist for Drug Product in North Carolina. The role drives Quality oversight from DP manufacturing readiness through startup to commercial operation, coordinating validation, lifecycle documentation, and regulatory readiness. You will support cross-functional teams, manage change controls, and collaborate with global peers to ensure compliant, on-time delivery in a fast-paced environment. Onsite role with some travel expected. #J-18808-Ljbffr FUJIFILM Holdings America Corporation
- Position Overview The QA Specialist, Drug Product (DP) helps drive the Quality oversight for the direction of all DP Manufacturing... ...systems are maintained in a validated state from startup into commercial... ...of experience working in a GMP regulated environment. Experience...SuggestedFlexible hours
- FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Validation to drive quality oversight for commissioning and qualification activities. You... ...validated states, and support change control in a GMP environment. The role emphasizes risk assessment,...Suggested
- ...Biotechnologies in Holly Springs, NC seeks a QA Specialist, Operations to provide QA oversight of Drug Substance Manufacturing processes and validate DSM systems throughout their lifecycle.... ...sites. This role requires 2+ years GMP experience or a master’s with related experience...Suggested
- ...Research Institute is seeking a QA Specialist, Operations in Holly Springs, NC... ...This role involves providing QA oversight for Drug Substance Manufacturing processes... ...or Engineering, 2+ years in a GMP environment, and knowledge of validation software. This position requires...SuggestedShift work
- ...Position Overview The QA Specialist, DSM Operations (Days... ...in the Quality oversight of Drug Substance Manufacturing... ...provides oversight of validation program execution for... ...drug substance production, fill-finish, and packaging... ...' experience in a GMP environment. ~ Experience...SuggestedFull timeImmediate startFlexible hoursShift work
- ...Carolina is seeking a Sr. Associate in Plant Quality Assurance (PQA) to provide crucial oversight during drug substance manufacturing. This role entails ensuring compliance with GMP and quality standards while collaborating with manufacturing teams to address any quality...
- ...Biotechnologies in Holly Springs, NC, seeks a QA Specialist, Operations to oversee DSM manufacturing processes and validation programs. You will ensure... ...a validated state and support QA oversight of day-to-day activities. The role requires GMP quality assurance experience,...Shift work
- Position Overview The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes... ...role provides oversight of validation program execution for these... ...1-3 years’ experience in a GMP environment. Experience in...Immediate startShift work
- ...leading pharmaceutical company in Holly Springs, North Carolina, seeks a QA specialist to provide quality support and oversight for commissioning, qualification, and Computer Systems Validation. The role involves managing QA oversight of various automation platforms,...
- ...PQA) provides on-the-floor quality oversight for bulk drug substance manufacturing and new product introductions. This role partners... ...to ensure real-time GMP decision-making, compliance, and... ...with batch records, deviations, and QA oversight Previous experience in...Shift work
- Fujifilm Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Validation, to drive quality oversight for commissioning and qualification processes. You will review and approve validation activities and maintain validated state for equipment and processes in...
$24 - $26 per hour
...that could potentially impact product quality are assessed according... ...samples, and testing areas • Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations. Seniority level... ...0 2 days ago Quality Assurance Specialist - cGMP Manufacturing Holly...Contract workRemote work$66.2k - $86.8k
...profile, we want to hear from you. The QA Specialist, External Manufacturing Quality Operations... ...compliance with procedures to support product disposition. Support release activities... ...across key quality assurance functions in a GMP setting (e.g., batch record review,...Work experience placementWork at office- This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation...
- ...improving corporate quality management systems. The ideal candidate will possess a BS in Chemistry or related fields and have experience in GMP laboratory settings. This position also offers a range of benefits including medical, dental, and vision insurance, as well as...
$98k - $182k
...to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is defined by Innovation -... ...scientific discipline and a minimum of five years of experience in a GMP setting. You have a proven experience building and maintaining...Local areaRelocation packageFlexible hours- ...description The Quality Assurance Specialist I is responsible for... ...management program that ensures the products and services the company... ...and Responsibilities QA review incoming client material... ...destruction QA review and approve validation documentation and other...Work experience placement
- ...Clean and organize the store mop room • Find more efficient ways to do the job and seek to reduce costs and improve labor productivity • Follow QA daily check list and sanitation standards set by Food Lion • Follow current Standard Practices regarding cleanup of...Local areaNight shift
- Eisai US is looking for a QA Specialist to support Quality Assurance activities in Cary, North Carolina. This role will involve batch record... ...management, and ensuring compliance with quality standards in a GMP environment. The ideal candidate should have a Bachelor’s...
$114.7k - $212.9k
...standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is... ...impactful Principal Quality Compliance Specialist who possesses extensive experience in quality... ...cross-functionally (Operations, MSAT, QA, QC, Engineering) and with global...Local areaRelocation package$40 - $43 per hour
...container closure integrity mechanisms. Resolve bottlenecks related to key changes. Authorship of Operating Standard and SOP revisions. Own GMP materials relating to area of responsibility. Participate in regulatory inspections and site audits as needed. Required/Basic...Hourly payTemporary workShift workNight shiftDay shift- A leading pharmaceutical company located in Holly Springs is seeking a Quality Assurance Associate to support inspections, sampling, and testing of raw materials. The role involves ensuring compliance with cGMP requirements, documenting test results, and participating in...
- ...Clean and organize the store mop room Find more efficient ways to do the job and seek to reduce costs and improve labor productivity Follow QA daily check list and sanitation standards set by Food Lion Follow current Standard Practices regarding cleanup of Hazardous...Local areaNight shift
- A manufacturing company in Cary, North Carolina, seeks a Quality Specialist to ensure that all manufactured parts meet quality standards with minimal waste. You will collaborate with design and production teams, conduct inspections and audits, and manage the quality management...
- ...time off Parental leave Vision insurance Overview The Quality Specialist is a key member of the Custom Cylinders team, responsible for... ...Manager, this role collaborates closely with the Design and Production Engineer to maintain and improve product quality and operational...
- Polyzen in Apex, NC is seeking a Document Control & Training Coordinator for a 1st shift, Monday-Friday 8:00 am-5:00 pm. You will ensure the effectiveness and compliance of the document management system and training program in support of FDA 21 CFR Part 820, ISO 13485 ...Monday to FridayDay shift
- Kleinfelder is seeking an experienced Senior Air Quality Professional to join our Environmental team in the South Division. The role focuses on air quality compliance programs, including emission inventories, permit applications, regulatory review, and GHG reporting, with...
- Infosoft Health is seeking a Quality Support Administrator in Cary, NC. This role involves managing FDA-regulated customer safety advisory notices for patient safety recalls and ensuring compliance with industry regulations. Candidates must hold a Bachelor's degree and ...
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